Feoza 45

Feoza 45 tablet is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause

Take one 45mgtablet orally once daily, with or without food. Swallow the tablet whole with liquids; do not cut, crush, or chew. Take it at approximately the same time each day. If a dose is missed, take it as soon as possible unless there are less than 12 hours before the next scheduled dose; in that case, skip the missed dose and resume the regular schedule the following day.

The efficacy and safety of Feoza 45  in individuals less than 18 years of age have not been established.

There have not been sufficient numbers of geriatric women involved in clinical trials utilizing Feoza 45 to determine whether those over 65 years of age differ from younger women in their response to Feoza 45.

Feoza 45 is contraindicated in women with known cirrhosis, severe renal impairment or end-stage renal disease, or concomitant use of CYP1A2 inhibitors.

Hepatic Transaminase Elevation and Hepatotoxicity: Elevations in serum transaminase concentrations greater than 3 times the upper limit of normal (ULN) occurred in the clinical trials. Perform hepatic laboratory tests prior to initiation of Feoza 45 to evaluate for hepatic function and injury. Patient should not start Feoza 45 if the concentration of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is equal to or exceeds 2 times the ULN or if the total bilirubin is elevated (for example, equal to or exceeds 2 times the ULN) for the evaluating laboratory. Patient should perform follow-up hepatic laboratory tests monthly for the frst 3 months, at 6 months, and 9 months after initiation of therapy.